oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder. A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Liebowitz social anxiety scale -self report (LSAS)
研究概览
简要总结
Social anxiety is characterised by excessive fear of being negatively judged, embarrassed or humiliated during social interactions and is common with a lifetime prevalence of 12.1%. Cognitive behavioural therapy is the first line of treatment, but people may not seek treatment due to a number of factors including the discomfort experienced in seeking help, inconvenience, and the experience of psychotherapy itself. With Virtual Reality (VR), users can have increased control in how gradually they expose themselves to social situations. In studies of VR in people with specific phobias, 76% of people prefer VR exposure to in vivo exposure. There is emerging evidence for the use of VR in social phobia.
oVRcome, is a self-help VRET for social anxiety symptoms and specific phobias, that is delivered through a smartphone application (app) in combination with a low cost headset that holds the smartphone and uses 360º video.
This study will evaluate the effectiveness of the oVRcome social anxiety program for social anxiety symptoms. We hypothesize that oVRcome will reduce social anxiety symptom severity over a 6-week treatment period compared to waiting-list control
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are between 18-64 years old
- •have moderate (or higher) social anxiety disorder symptoms on Liebowitz social anxiety scale (>60)
- •have access to a smart phone and internet
- •willing to participate in the research study and providing informed consent
排除标准
- •present with symptoms of severe depression or suicidality respectively as measured with the PHQ-9; total score > 19, =3 on suicidality item
- •have insufficient knowledge of the English language
- •are under current treatment for social phobia or psychotropic medication (unless on stable dosage for the previous 3 months and no changes planned during the study period).
结局指标
主要结局
Liebowitz social anxiety scale -self report (LSAS)
时间窗: Week 6
Assesses the way that social phobia plays a role in participants life across a variety of situations. Higher scores indicate more severe symptoms. Min 0 Max 144
次要结局
- Brief Fear of Negative Evaluation Scale(week 0,6,12,18)
- Modified Gatineau Presence Questionnaire First item(Week 4,5,6)
- Patient Health Questionnaire - PHQ 9(Week 0,6,12,18)
- Changes in behaviour that may have been previously avoided because of the phobia(Week 6,12,18)
- Patient's Global Impressions of Improvement (PGI-I) scale(Week 1,2,3,4,5,6,7,8,9,10,11,12,18)
- Fast Motion Sickness Scale (FMS)(Week 4,5,6)